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Chemistry

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Also known as: 25122-46-7, Clobetasol 17-propionate, Clobex, Dermovate, Temovate, Embeline
Molecular Formula
C25H32ClFO5
Molecular Weight
467.0  g/mol
InChI Key
CBGUOGMQLZIXBE-XGQKBEPLSA-N
FDA UNII
779619577M

Clobetasol Propionate
A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression.
1 2D Structure

Clobetasol Propionate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(8S,9R,10S,11S,13S,14S,16S,17R)-17-(2-chloroacetyl)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate
2.1.2 InChI
InChI=1S/C25H32ClFO5/c1-5-21(31)32-25(20(30)13-26)14(2)10-18-17-7-6-15-11-16(28)8-9-22(15,3)24(17,27)19(29)12-23(18,25)4/h8-9,11,14,17-19,29H,5-7,10,12-13H2,1-4H3/t14-,17-,18-,19-,22-,23-,24-,25-/m0/s1
2.1.3 InChI Key
CBGUOGMQLZIXBE-XGQKBEPLSA-N
2.1.4 Canonical SMILES
CCC(=O)OC1(C(CC2C1(CC(C3(C2CCC4=CC(=O)C=CC43C)F)O)C)C)C(=O)CCl
2.1.5 Isomeric SMILES
CCC(=O)O[C@@]1([C@H](C[C@@H]2[C@@]1(C[C@@H]([C@]3([C@H]2CCC4=CC(=O)C=C[C@@]43C)F)O)C)C)C(=O)CCl
2.2 Other Identifiers
2.2.1 UNII
779619577M
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Clobetasol

2. Clobetasol 17 Propionate

3. Clobetasol 17-propionate

4. Clobex

5. Clofenazon

6. Cormax

7. Dermovate

8. Embeline

9. Embeline E

10. Olux

11. Temovate

2.3.2 Depositor-Supplied Synonyms

1. 25122-46-7

2. Clobetasol 17-propionate

3. Clobex

4. Dermovate

5. Temovate

6. Embeline

7. Cormax

8. Olux

9. Gr 2/925

10. Cci 4725

11. Clobestasol Propionate

12. Impoyz

13. Psorex

14. [(8s,9r,10s,11s,13s,14s,16s,17r)-17-(2-chloroacetyl)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] Propanoate

15. Clobetasol 17-propanoate

16. Clobetasol-17-propionate

17. Mls000028708

18. Cci-4725

19. 21-chloro-9-fluoro-11beta,17-dihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17-propionate

20. Embeline E

21. Smr000058745

22. Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11beta,16beta)-

23. Clobesol

24. Chebi:31414

25. Temovate E

26. Nsc-758634

27. Dsstox_cid_25907

28. Dsstox_rid_81219

29. Dsstox_gsid_45907

30. Olux-e

31. 779619577m

32. Dermoxinale

33. Butavate

34. Dermoval

35. Yugofin

36. 21-chloro-9-fluoro-11beta-hydroxy-16beta-methyl-3,20-dioxopregna-1,4-dien-17-yl Propanoate

37. Olux E

38. Cgp 9555

39. Clobetasol Propionate Gel

40. Einecs 246-634-3

41. Clobetasol Propionate (emollient)

42. Clarelux

43. Ncgc00095078-01

44. Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11.beta.,16.beta.)-

45. Clobetasol-propionate

46. Cas-25122-46-7

47. Clobex (tn)

48. Cormax (tn)

49. Mfcd00058499

50. Unii-779619577m

51. Impeklo

52. Clobetasol Propionate [usan:usp:jan]

53. Olux (tn)

54. Clobetasol Propionate E

55. Propionic Acid Clobetasol

56. Opera_id_1470

57. Schembl3997

58. 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione (11beta,16beta)-

59. Cid_32798

60. Mls001076345

61. Amot0927

62. Gtpl7062

63. Ccl 4725

64. Chembl1159650

65. Dtxsid6045907

66. Bdbm39347

67. Cgp9555

68. Clobetasol Propionate [mi]

69. Hms2090a04

70. Hms2230h08

71. Hms3259a10

72. Hms3714m04

73. Clobetasol Propionate (jp17/usp)

74. Clobetasol Propionate [jan]

75. Bcp04125

76. Zinc3977767

77. Clobetasol Propionate [usan]

78. Tox21_111414

79. Am9637

80. Clobetasol Propionate [vandf]

81. S2584

82. Clobetasol Propionate [mart.]

83. Akos015951278

84. Clobetasol Propionate [usp-rs]

85. Clobetasol Propionate [who-dd]

86. Tox21_111414_1

87. Bcp9000539

88. Ccg-220781

89. Clobetasol 17-propionate [mi]

90. Db01013

91. Nc00551

92. Nsc 758634

93. 21-chloro-9-fluoro-11beta-hydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17-propionate

94. Ncgc00023373-03

95. Ncgc00023373-04

96. Ac-17990

97. As-12555

98. Clobetasol Propionate, Analytical Standard

99. Cpd000058745

100. Gr-2/925

101. Hy-13600

102. Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-beta,17-dihydroxy-16-beta-methyl-, 17-propionate

103. Bcp0726000094

104. Clobetasol Propionate [orange Book]

105. Clobetasol Propionate [usp Impurity]

106. Clobetasol Propionate [usp Monograph]

107. D01272

108. D94623

109. Ab00383081-10

110. Ab00383081_11

111. 122c467

112. Clobetasol Propionate 1000 Microg/ml In Methanol

113. Q421637

114. Sr-01000000280

115. Clobetasol Propionate 100 Microg/ml In Acetonitrile

116. Sr-01000000280-4

117. Brd-k10799896-001-10-6

118. Brd-k10799896-001-26-2

119. Clobetasol Propionate 100 Microg/ml In Methanol/water

120. Clobetasol Propionate, European Pharmacopoeia (ep) Reference Standard

121. Clobetasol Propionate, United States Pharmacopeia (usp) Reference Standard

122. Clobetasol For Peak Identification, European Pharmacopoeia (ep) Reference Standard

123. Clobetasol Propionate, Pharmaceutical Secondary Standard; Certified Reference Material

124. (8alpha,11beta,14beta,16alpha,17alpha)-21-chloro-9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl Propanoate

125. 21-chloro-9-fluoro-11.beta.,17-dihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione 17-propionate

126. 21-chloro-9alpha-fluoro-11beta,17alpha-dihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione 17-propionate

127. Cgp9555 Pound>> Ccl 4725 Pound>>cgp 9555 Pound>> Ccl4725 Pound>>cgp-9555 Pound>> Ccl-4725

128. Xrd

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 467.0 g/mol
Molecular Formula C25H32ClFO5
XLogP33.8
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count5
Exact Mass466.1922300 g/mol
Monoisotopic Mass466.1922300 g/mol
Topological Polar Surface Area80.7 Ų
Heavy Atom Count32
Formal Charge0
Complexity929
Isotope Atom Count0
Defined Atom Stereocenter Count8
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 20  
Drug NameClobetasol propionate
Active IngredientClobetasol propionate
Dosage FormLotion; Gel; Shampoo; Ointment; Cream; Spray; Aerosol, foam; Solution
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyWockhardt; Fougera Pharms; Teva Pharms; Paddock; Actavis Mid Atlantic; Perrigo; Taro; Fougera; Tolmar; Perrigo Israel

2 of 20  
Drug NameClobetasol propionate
PubMed HealthClobetasol Propionate (On the skin)
Drug ClassesCorticosteroid, Very Strong
Drug LabelClobetasol propionate cream USP, 0.05% (emollient) contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degre...
Active IngredientClobetasol propionate
Dosage FormCream
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyFougera Pharms; Taro

3 of 20  
Drug NameClobex
Drug LabelCLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflamm...
Active IngredientClobetasol propionate
Dosage FormLotion; Shampoo; Spray
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyGalderma Labs

4 of 20  
Drug NameCormax
PubMed HealthClobetasol Propionate (On the skin)
Drug ClassesCorticosteroid, Very Strong
Drug LabelCormax Ointment contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid...
Active IngredientClobetasol propionate
Dosage FormCream
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyHi Tech Pharma

5 of 20  
Drug NameEmbeline
Drug LabelClobetasol propionate foam, 0.05% contains clobetasol propionate, USP, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocortic...
Active IngredientClobetasol propionate
Dosage FormGel; Ointment; Solution
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyHi Tech Pharma

6 of 20  
Drug NameEmbeline e
Active IngredientClobetasol propionate
Dosage FormCream
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyHi Tech Pharma

7 of 20  
Drug NameOlux
PubMed HealthClobetasol
Drug ClassesCorticosteroid, Very Strong, Corticosteroid, Weak
Drug LabelOLUX-E (clobetasol propionate) Foam, 0.05% is a white to off-white petrolatum-based emulsion aerosol foam containing the active ingredient clobetasol propionate USP, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of pr...
Active IngredientClobetasol propionate
Dosage FormAerosol, foam
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyDelcor Asset

8 of 20  
Drug NameOlux e
PubMed HealthClobetasol
Drug ClassesCorticosteroid, Very Strong, Corticosteroid, Weak
Active IngredientClobetasol propionate
Dosage FormAerosol, foam
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyDelcor Asset

9 of 20  
Drug NameTemovate
PubMed HealthClobetasol
Drug ClassesCorticosteroid, Very Strong, Corticosteroid, Weak
Drug LabelTemovate E (clobetasol propionate) Cream, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree...
Active IngredientClobetasol propionate
Dosage FormOintment; Cream; Gel
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyFougera Pharms

10 of 20  
Drug NameTemovate e
PubMed HealthClobetasol Propionate (On the skin)
Drug ClassesCorticosteroid, Very Strong
Drug LabelTemovate E (clobetasol propionate) Cream, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree...
Active IngredientClobetasol propionate
Dosage FormCream
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyFougera Pharms

11 of 20  
Drug NameClobetasol propionate
Active IngredientClobetasol propionate
Dosage FormLotion; Gel; Shampoo; Ointment; Cream; Spray; Aerosol, foam; Solution
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyWockhardt; Fougera Pharms; Teva Pharms; Paddock; Actavis Mid Atlantic; Perrigo; Taro; Fougera; Tolmar; Perrigo Israel

12 of 20  
Drug NameClobetasol propionate
PubMed HealthClobetasol Propionate (On the skin)
Drug ClassesCorticosteroid, Very Strong
Drug LabelClobetasol propionate cream USP, 0.05% (emollient) contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degre...
Active IngredientClobetasol propionate
Dosage FormCream
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyFougera Pharms; Taro

13 of 20  
Drug NameClobex
Drug LabelCLOBEX (clobetasol propionate) Lotion, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflamm...
Active IngredientClobetasol propionate
Dosage FormLotion; Shampoo; Spray
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyGalderma Labs

14 of 20  
Drug NameCormax
PubMed HealthClobetasol Propionate (On the skin)
Drug ClassesCorticosteroid, Very Strong
Drug LabelCormax Ointment contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid...
Active IngredientClobetasol propionate
Dosage FormCream
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyHi Tech Pharma

15 of 20  
Drug NameEmbeline
Drug LabelClobetasol propionate foam, 0.05% contains clobetasol propionate, USP, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocortic...
Active IngredientClobetasol propionate
Dosage FormGel; Ointment; Solution
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyHi Tech Pharma

16 of 20  
Drug NameEmbeline e
Active IngredientClobetasol propionate
Dosage FormCream
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyHi Tech Pharma

17 of 20  
Drug NameOlux
PubMed HealthClobetasol
Drug ClassesCorticosteroid, Very Strong, Corticosteroid, Weak
Drug LabelOLUX-E (clobetasol propionate) Foam, 0.05% is a white to off-white petrolatum-based emulsion aerosol foam containing the active ingredient clobetasol propionate USP, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of pr...
Active IngredientClobetasol propionate
Dosage FormAerosol, foam
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyDelcor Asset

18 of 20  
Drug NameOlux e
PubMed HealthClobetasol
Drug ClassesCorticosteroid, Very Strong, Corticosteroid, Weak
Active IngredientClobetasol propionate
Dosage FormAerosol, foam
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyDelcor Asset

19 of 20  
Drug NameTemovate
PubMed HealthClobetasol
Drug ClassesCorticosteroid, Very Strong, Corticosteroid, Weak
Drug LabelTemovate E (clobetasol propionate) Cream, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree...
Active IngredientClobetasol propionate
Dosage FormOintment; Cream; Gel
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyFougera Pharms

20 of 20  
Drug NameTemovate e
PubMed HealthClobetasol Propionate (On the skin)
Drug ClassesCorticosteroid, Very Strong
Drug LabelTemovate E (clobetasol propionate) Cream, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree...
Active IngredientClobetasol propionate
Dosage FormCream
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyFougera Pharms

4.2 Drug Indication

Clobetasol propionate is indicated to treat moderate to severe plaque psoriasis as well as inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Clobetasol propionate is generally applied twice daily so the duration of action is long. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.


5.2 MeSH Pharmacological Classification

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)


Glucocorticoids

A group of CORTICOSTEROIDS that affect carbohydrate metabolism (GLUCONEOGENESIS, liver glycogen deposition, elevation of BLOOD SUGAR), inhibit ADRENOCORTICOTROPIC HORMONE secretion, and possess pronounced anti-inflammatory activity. They also play a role in fat and protein metabolism, maintenance of arterial blood pressure, alteration of the connective tissue response to injury, reduction in the number of circulating lymphocytes, and functioning of the central nervous system. (See all compounds classified as Glucocorticoids.)


5.3 FDA Pharmacological Classification
5.3.1 Pharmacological Classes
Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
5.4 Absorption, Distribution and Excretion

Absorption

Twice daily application of clobetasol foam leads to a Cmax of 5936pg/mL with a Tmax of 5 hours. Clobetasol cream showed an increase in clobetasol concentrations from 50.796.0pg/mL to 56.3104.7pg/mL.


Route of Elimination

Corticosteroids are eliminated predominantly in the urine.


Volume of Distribution

Data regarding the volume of distribution of clobetasole propionate are not readily available.


Clearance

Data regarding the clearance of clobetasol propionate are not readily available.


5.5 Metabolism/Metabolites

The metabolism of clobetasol propionate is not well studied but it does induce metabolic enzymes, even when delivered topically. The metabolism of clobetasol propionate is predicted to follow similar metabolic pathways to other corticosteroids including the addition of oxygen, hydrogen, glucuronides, and sulfates to form water soluble metabolites.


5.6 Biological Half-Life

Data regarding the half life of clobetasol propionate are not readily available.


5.7 Mechanism of Action

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.


API Reference Price

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03-Jan-2022
30-Apr-2025
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DOSAGE - CREAM;TOPICAL - 0.05% **Federal Regi...DOSAGE - CREAM;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20340

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DOSAGE - CREAM;TOPICAL - 0.025%

USFDA APPLICATION NUMBER - 209483

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DOSAGE - AEROSOL, FOAM;TOPICAL - 0.05%

USFDA APPLICATION NUMBER - 21142

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DOSAGE - LOTION;TOPICAL - 0.05%

USFDA APPLICATION NUMBER - 213691

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DOSAGE - LOTION;TOPICAL - 0.05%

USFDA APPLICATION NUMBER - 21535

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DOSAGE - SHAMPOO;TOPICAL - 0.05%

USFDA APPLICATION NUMBER - 21644

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DOSAGE - AEROSOL, FOAM;TOPICAL - 0.05% **Fede...DOSAGE - AEROSOL, FOAM;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22013

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ABOUT THIS PAGE

Looking for 25122-46-7 / Clobetasol Propionate API manufacturers, exporters & distributors?

Clobetasol Propionate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Clobetasol Propionate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Clobetasol Propionate manufacturer or Clobetasol Propionate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clobetasol Propionate manufacturer or Clobetasol Propionate supplier.

PharmaCompass also assists you with knowing the Clobetasol Propionate API Price utilized in the formulation of products. Clobetasol Propionate API Price is not always fixed or binding as the Clobetasol Propionate Price is obtained through a variety of data sources. The Clobetasol Propionate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Clobetasol Propionate

Synonyms

25122-46-7, Clobetasol 17-propionate, Clobex, Dermovate, Temovate, Embeline

Cas Number

25122-46-7

Unique Ingredient Identifier (UNII)

779619577M

About Clobetasol Propionate

A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression.

Clobetasol 17-Propionate Manufacturers

A Clobetasol 17-Propionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clobetasol 17-Propionate, including repackagers and relabelers. The FDA regulates Clobetasol 17-Propionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clobetasol 17-Propionate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Clobetasol 17-Propionate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Clobetasol 17-Propionate Suppliers

A Clobetasol 17-Propionate supplier is an individual or a company that provides Clobetasol 17-Propionate active pharmaceutical ingredient (API) or Clobetasol 17-Propionate finished formulations upon request. The Clobetasol 17-Propionate suppliers may include Clobetasol 17-Propionate API manufacturers, exporters, distributors and traders.

click here to find a list of Clobetasol 17-Propionate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Clobetasol 17-Propionate USDMF

A Clobetasol 17-Propionate DMF (Drug Master File) is a document detailing the whole manufacturing process of Clobetasol 17-Propionate active pharmaceutical ingredient (API) in detail. Different forms of Clobetasol 17-Propionate DMFs exist exist since differing nations have different regulations, such as Clobetasol 17-Propionate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Clobetasol 17-Propionate DMF submitted to regulatory agencies in the US is known as a USDMF. Clobetasol 17-Propionate USDMF includes data on Clobetasol 17-Propionate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clobetasol 17-Propionate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Clobetasol 17-Propionate suppliers with USDMF on PharmaCompass.

Clobetasol 17-Propionate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Clobetasol 17-Propionate Drug Master File in Japan (Clobetasol 17-Propionate JDMF) empowers Clobetasol 17-Propionate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Clobetasol 17-Propionate JDMF during the approval evaluation for pharmaceutical products. At the time of Clobetasol 17-Propionate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Clobetasol 17-Propionate suppliers with JDMF on PharmaCompass.

Clobetasol 17-Propionate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Clobetasol 17-Propionate Drug Master File in Korea (Clobetasol 17-Propionate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clobetasol 17-Propionate. The MFDS reviews the Clobetasol 17-Propionate KDMF as part of the drug registration process and uses the information provided in the Clobetasol 17-Propionate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Clobetasol 17-Propionate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Clobetasol 17-Propionate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Clobetasol 17-Propionate suppliers with KDMF on PharmaCompass.

Clobetasol 17-Propionate CEP

A Clobetasol 17-Propionate CEP of the European Pharmacopoeia monograph is often referred to as a Clobetasol 17-Propionate Certificate of Suitability (COS). The purpose of a Clobetasol 17-Propionate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clobetasol 17-Propionate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clobetasol 17-Propionate to their clients by showing that a Clobetasol 17-Propionate CEP has been issued for it. The manufacturer submits a Clobetasol 17-Propionate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clobetasol 17-Propionate CEP holder for the record. Additionally, the data presented in the Clobetasol 17-Propionate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clobetasol 17-Propionate DMF.

A Clobetasol 17-Propionate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clobetasol 17-Propionate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Clobetasol 17-Propionate suppliers with CEP (COS) on PharmaCompass.

Clobetasol 17-Propionate WC

A Clobetasol 17-Propionate written confirmation (Clobetasol 17-Propionate WC) is an official document issued by a regulatory agency to a Clobetasol 17-Propionate manufacturer, verifying that the manufacturing facility of a Clobetasol 17-Propionate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Clobetasol 17-Propionate APIs or Clobetasol 17-Propionate finished pharmaceutical products to another nation, regulatory agencies frequently require a Clobetasol 17-Propionate WC (written confirmation) as part of the regulatory process.

click here to find a list of Clobetasol 17-Propionate suppliers with Written Confirmation (WC) on PharmaCompass.

Clobetasol 17-Propionate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Clobetasol 17-Propionate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Clobetasol 17-Propionate API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Clobetasol 17-Propionate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Clobetasol 17-Propionate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clobetasol 17-Propionate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Clobetasol 17-Propionate suppliers with NDC on PharmaCompass.

Clobetasol 17-Propionate GMP

Clobetasol 17-Propionate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Clobetasol 17-Propionate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Clobetasol 17-Propionate GMP manufacturer or Clobetasol 17-Propionate GMP API supplier for your needs.

Clobetasol 17-Propionate CoA

A Clobetasol 17-Propionate CoA (Certificate of Analysis) is a formal document that attests to Clobetasol 17-Propionate's compliance with Clobetasol 17-Propionate specifications and serves as a tool for batch-level quality control.

Clobetasol 17-Propionate CoA mostly includes findings from lab analyses of a specific batch. For each Clobetasol 17-Propionate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Clobetasol 17-Propionate may be tested according to a variety of international standards, such as European Pharmacopoeia (Clobetasol 17-Propionate EP), Clobetasol 17-Propionate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clobetasol 17-Propionate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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